Manager, Regulatory Affairs

Job Description

Specific Education & Experience Requirements:

• 5+ years of experience in Regulatory Affairs or other relevant industry experience.

• Degree in a scientific field is preferred.

Specific Job Responsibilities:

• Responsible for preparing regulatory submissions which require interactions with departments outside of Regulatory Affairs for investigational and commercial products for assigned territories in line with ICH requirements, regional requirements and scientific and company policies and procedures.

• Responsible for submissions which may include safety reports, amendments, supplements and license renewals to clinical trial applications (e.g. IND, CTAs), and marketing authorizations), original, marketing authorization applications for territories other than the US and EU and for contributing to preparation of US and EU marketing authorizations).

• Provides regulatory expertise to labeling changes and to submission teams on specified projects and topics.

• Provides input to senior Regulatory Affairs professionals in the preparation of country specific labeling.

• May be responsible for ensuring product packaging and associated information is updated and maintained in accordance with the product licenses.

• Participate in group meetings and local and global product submission team meetings and present project status updates and strategy approaches to moderately complex programs/projects.

• Responsible under guidance of immediate manager for own self-development and acquisition of required regulatory skills and knowledge.

• Initiates or contribute to local process improvements which have an impact on the working of the Regulatory Affairs function or other departments.

• Excellent organization skills and ability to work on a number of projects with tight timelines is required.

• Excellent verbal and written communication skills and interpersonal skills are required.

• Must have in-depth knowledge of regulatory requirements, including ICH requirements and regional requirements for assigned territories. Is recognized as a knowledgeable resource within the department on a range of topics.

• Work is performed under minimal direction of a senior Regulatory Affairs professional.